TIDMAKT
RNS Number : 7278R
Ark Therapeutics Group PLC
09 November 2011
Ark Therapeutics Group plc
Interim Management Statement
9 November 2011 - Ark Therapeutics Group plc ("Ark" or the
"Company") today publishes its interim management statement for the
period from 1 July 2011 to date.
Manufacturing
We are continuing to focus on exploiting our world leading cGMP
Biosafety level 2 certified manufacturing facility in Kuopio,
Finland. In September we announced that we had signed a
manufacturing partnership agreement with PsiOxus Therapeutics Ltd
("PsiOxus") under which we are now providing full manufacturing and
related services to support the development of PsiOxus' ColoAd1
programme for the treatment of colorectal cancer utilising Ark's
suspension based single use system (ATOSUS). In November we
announced that we had also signed a manufacturing agreement with
University of Glasgow's Institute of Cardiovascular and Medical
Sciences in respect of the Institute's gene-therapy programme for
the treatment of vein graft failure associated with coronary artery
bypass surgery. The contract was awarded following our success in
an open competitive tender process under public body procurement
rules.
We continue with detailed discussions with a number of other
interested parties who wish to avail themselves of Ark's
bio-manufacturing expertise and we hope to announce further
partnerships in the following months.
Breakthrough work by Ark's scientists in creating a scalable
platform for lentiviral vector manufacture was published in the
June 2011 issue of the journal "Gene Therapy".
Grants
On 6 July we announced the securing of EUR0.6 million in Finnish
grants, and later that month we announced that the Company is part
of a consortium which had won a EUR5.3m EU Framework Programme 7
Grant, of which Ark would be receiving approximately EUR1.1m for
its contribution over the term of the project.
Intellectual Property
In early July we announced that the United States Patent and
Trademark Office ("USPTO") had issued Notices of Allowance in
respect of two patents for which certain rights have been assigned
by Ark to Boehringer Ingelheim. The patents cover the use of
Boehringer Ingelheim's compound Telmisartan for the prevention and
treatment of stroke and the prevention of myocardial infarction
related heart damage. The patents were formally granted by the
USPTO in August triggering significant milestone payments, now
received, under Ark's licence agreement with Boehringer Ingelheim.
This was excellent news for both Ark and Boehringer Ingelheim and a
further validation of Ark's intellectual property.
Product Pipeline
Neuropilin-1 Receptor Antagonists (EG014)- Ark has developed the
only known drug-like small molecule antagonists of VEGF binding to
Neuropilin-1 (NRP-1). The binding to NRP-1 results in three
activities of likely benefit as an anti-cancer therapy: inhibition
of tumour cell proliferation, inhibition of tumour cell migration
and inhibition of angiogenesis. During the current reporting period
Ark's scientists have published studies on site-directed mutants of
NRP-1 that specifically abolish VEGF binding and provide further
validation of the potential therapeutic value of the antagonists.
Ark has also continued to invest in the lead optimisation of these
molecules, assisted by X-ray crystallographic structures of
complexes of antagonists with NRP-1. These efforts have reinforced
Ark's dominant scientific and patent positions in the field. Ark
considers that the programme constitutes an attractive partnering
package and is seeking companies that will be able to support its
further development. In the interims announcement issued on 24
August we reported that AstraZeneca have received some of Ark's
compounds to evaluate in their own assays.
Refractory Angina (EG011) -Refractory angina is a consequence of
insufficient blood supply to the areas of heart muscle damaged by a
heart attack. Ark's adenoviral vector carrying a transgene for
expression of pro-angiogenic human VEGF-D is designed to treat the
condition by stimulating new blood vessel generation at the
ischemic heart muscle to which it is directly administered. An
academic clinical study of this treatment is in progress in Finland
to gain early insights into the safety and efficacy of the
treatment. The study is progressing through an initial dose ranging
phase that is on course to complete recruitment by the end of 2011
or early 2012.
Peripheral Vascular Disease (EG016) - Like refractory angina,
this programme utilises the angiogenic properties of Ad.VEGF-D. The
vector is delivered into the muscle of the affected limb a number
of days before surgery, to promote the growth of smaller vessels
needed to take blood flow from the vessel that has been unblocked
by bypass or angioplasty. As with refractory angina, early insights
into the safety and efficacy of the treatment are anticipated from
an academic clinical study being undertaken in Finland, the results
of which will be used to form the basis of formal development
programmes with partners.
Foetal Growth Restriction (FGR) (EG013) -this program represents
another potential therapeutic application of Ark's pro-angiogenic
Ad.VEGF-D gene vector. Severe foetal growth restriction, which
represents a major unmet clinical need, is a consequence of
inadequate placental blood supply. By treating the maternal uterine
artery with Ad.VEGF, Ark's academic collaborators have demonstrated
in appropriate models that maternal blood supply to the foetus can
be improved with positive outcomes for its growth. Ark is now
investigating the investment required to progress this highly
promising therapy into the toxicology study that has been discussed
with the regulatory authorities as a pre-requisite for clinical
trials.
We also continue to work very actively on partnering programmes,
including Cerepro(R).
Cash
As we reported in our interim results on 24 August 2011, the
Company had GBP5.4m in cash (excluding the Finnish working capital
loan of EUR3m in restricted cash) at 30 June 2011. The significant
milestone payments received from Boehringer Ingelheim during the
period, the recently announced important manufacturing contracts
with PsiOxus and the University of Glasgow, the Company's success
in attracting grant funding and the Company's continued focus on
controlling costs, have all served to bolster the Company's cash
reserves. It is expected that cash reserves will be higher at the
end of the current year than they were at the end of June 2011.
The Board continues to review detailed cash forecasts on a
regular basis.
Martyn Williams, CEO of Ark, commented:
"Since the announcement of our interim results on 24 August
2011, we were delighted to report that the late-stage discussions
with a number of potential manufacturing partners which we reported
at that time have already resulted in two important contracts which
we have announced recently. With further discussions ongoing across
all our activities, and the strengthened cash position, we remain
confident of being able to deliver the remaining short-term
objectives."
Enquiries
Ark Therapeutics Group plc Tel: +44 (0)20 7388 7722
Martyn Williams, Chief Executive
Officer
Iain Ross, Executive Chairman
FTI Consulting Tel: +44 (0)20 7831 3113
Ben Atwell/Sue Quigley
Ark Therapeutics Group plc
Ark Therapeutics Group plc is a specialist healthcare group (the
"Group") addressing high value areas of unmet medical need within
vascular disease and cancer. These are large and growing markets,
where opportunities exist for effective new products to generate
significant revenues.
Ark has an early stage pipeline emanating from collaborations
with University College, London and the AI Virtanen Institute in
Kuopio, Finland, the development of which it intends to progress in
collaboration with pharmaceutical and biotech partners.
In addition Ark has the ability to off-set a proportion of its
R&D costs and to generate sustainable revenues through the
exploitation of its proprietary technology platform, process
development, scale-up and manufacturing capabilities on behalf of
third parties.
Ark has its origins in businesses established in the mid-1990s
by Professor John Martin of University College London and Professor
Seppo Yla-Herttuala of the AI Virtanen Institute at the University
of Kuopio, Finland, both of whom remain consultants on the
Company's research and development programmes.
Ark's shares were first listed on the London Stock Exchange in
March 2004 (AKT.L).
This announcement includes "forward-looking statements" which
include all statements other than statements of historical facts,
including, without limitation, those regarding the Group's
financial position, business strategy, plans and objectives of
management for future operations (including development plans and
objectives relating to the Group's products and services), and any
statements preceded by, followed by or that include forward-looking
terminology such as the words "targets", "believes", "estimates",
"expects", "aims", "intends", "will", "can", "may", "anticipates",
"would", "should", "could" or similar expressions or the negative
thereof. Such forward-looking statements involve known and unknown
risks, uncertainties and other important factors beyond the Group's
control that could cause the actual results, performance or
achievements of the Group to be materially different from future
results, performance or achievements expressed or implied by such
forward-looking statements. Such forward-looking statements are
based on numerous assumptions regarding the Group's present and
future business strategies and the environment in which the Group
will operate in the future. Among the important factors that could
cause the Group's actual results, performance or achievements to
differ materially from those in forward-looking statements include
those relating to Ark's funding requirements, regulatory approvals,
clinical trials, reliance on third parties, intellectual
property, key personnel and other factors. These forward-looking
statements speak only as at the date of this announcement. The
Group expressly disclaims any obligation or undertaking to
disseminate any updates or revisions to any forward-looking
statements contained in this announcement to reflect any change in
the Group's expectations with regard thereto or any change in
events, conditions or circumstances on which any such statements
are based. As a result of these factors, readers are cautioned not
to rely on any forward-looking statement.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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